BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MEDICUS

    MDR report key: 6993646 · Received November 1, 2017

    Report

    Report Number
    2184009-2017-00042
    Event Type
    Injury
    Date Received
    November 1, 2017
    Date of Event
    July 23, 2013
    Report Date
    November 1, 2017
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K924642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MINERVA ANESTESIOL. 2013 OCT;79(10):1147-55. EPUB 2013 SEP 3. DATE OF PUBLISH USED FOR EVENT DATE. MEDIAN PATIENT AGE OF STUDY POPULATION USED FOR PATIENT AGE. MAJORITY GENDER OF STUDY POPULATION USED FOR PATIENT GENDER. NO UNIQUE DEVICE IDENTIFIER (MODEL/LOT) NUMBERS WERE PROVIDED, THEREFORE THE SUSPECT MEDICAL DEVICE INFORMATION WAS ARBITRARILY CHOSEN. THE CORRESPONDING 510K NUMBER WAS SELECTED BASED ON THE ARBITRARY MODEL NUMBER. WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. MEDTRONIC HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION ON THE EVENT AND RETURN OF THE PRODUCT, BUT NO INFORMATION HAS BEEN RECEIVED TO DATE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING SURVIVAL RATES AND OVERALL QUALITY OF LIFE FOR PATIENTS WHO RECEIVED EMERGENCY VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) FOLLOWING REFRACTORY CIRCULATORY COLLAPSE. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2008 AND JUNE 2011. THE STUDY POPULATION INCLUDED 16 PATIENTS (PREDOMINANTLY MALE; MEDIAN AGE 54 YEARS), ALL OF WHICH WERE CONNECTED TO AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT CONTAINING A MEDTRONIC BIO-MEDICUS FEMORAL CANNULA (LOT AND MODEL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, THREE CASES OF HEMORRHAGING AT THE CANNULATION SITE REQUIRING SURGICAL INTERVENTION WERE REPORTED. AMONG ALL PATIENTS, NO MEDTRONIC DEVICE MALFUNCTIONS WERE NOTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771937 BIO-MEDICUS CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF PERFUSION SYSTEMS CB96570-019 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention